U.S. patent number 5,033,477 [Application Number 07/404,957] was granted by the patent office on 1991-07-23 for method and apparatus for providing intrapericardial access and inserting intrapericardial electrodes.
This patent grant is currently assigned to Thomas J. Fogarty, Ventritex, Inc.. Invention is credited to Albert K. Chin, Eric S. Fain, Thomas J. Fogarty.
United States Patent |
5,033,477 |
Chin , et al. |
July 23, 1991 |
Method and apparatus for providing intrapericardial access and
inserting intrapericardial electrodes
Abstract
Intrapericardial access is provided by clamping the wall of the
pericardium between elongate jaw elements carrying axially aligned
tubular guides and passing a guide wire through the guides and the
pericardial tissue therebetween. In the preferred embodiment the
jaw elements include interengageable ratchets for holding the
elements in clamping engagement with the wall of the pericardium
and aligned pointed extensions for piercing the pericardial tissue
clamped between the elements. Further intrapericardial access is
provided by an additional tubular guide carried by the jaw element
intended to be disposed in the pericardium during placement of the
guide wire.
Inventors: |
Chin; Albert K. (Palo Alto,
CA), Fogarty; Thomas J. (Portola Valley, CA), Fain; Eric
S. (Menlo Park, CA) |
Assignee: |
Fogarty; Thomas J. (Portola
Valley, CA)
Ventritex, Inc. (Sunnyvale, CA)
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Family
ID: |
23601714 |
Appl.
No.: |
07/404,957 |
Filed: |
September 8, 1989 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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120590 |
Nov 13, 1987 |
4865037 |
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Current U.S.
Class: |
607/131 |
Current CPC
Class: |
A61N
1/0587 (20130101) |
Current International
Class: |
A61N
1/05 (20060101); A61N 001/05 (); A61N 001/39 () |
Field of
Search: |
;128/419D,419P,784,785,786,642 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
"Implantation of the Automatic Defibrillator: The Subxiphoid
Approach"; pp. 515 through 520; Nov. 1982; Levi Watkins, Jr., M.D.
et al..
|
Primary Examiner: Kamm; William E.
Assistant Examiner: Schaetzle; Kennedy J.
Attorney, Agent or Firm: Limbach, Limbach & Sutton
Parent Case Text
RELATED APPLICATION
This is a continuation-in-part of copending application Ser. No.
120,590, filed Nov. 13, 1987, now U.S. Pat. No. 4,865,037.
Claims
We claim:
1. A method for implanting an electrode within the interior of the
pericardium, comprising the steps of:
(a) creating a subxiphoid incision;
(b) dissecting a tunnel between the pericardium and the diaphragm
from the subxiphoid incision towards the posterior aspect of the
pericardium;
(c) making a pericardial incision in the inferior border of the
pericardium;
(d) providing a clamp-like placement device having elongate tubular
jaws with aligned open distal ends curved toward one another;
(e) passing one of the jaws through the pericardial incision to
locate the curved end of said one jaw at a posterior position
within the pericardium;
(f) passing the other of the jaws into the tunnel to the exterior
of the pericardium to locate the curved end of said other jaw in
alignment with the curved end of said one jaw;
(g) passing a guide wire through the jaws to extend the wire within
and through the pericardium;
(h) removing the placement device while leaving the guide wire in
place;
(i) extending a cannula over the wire within the tunnel to pass the
cannula through the tunnel and into the pericardium; and,
(j) passing an electrode through the cannula and into the
pericardium to one side of the heart.
2. A method according to claim 1 wherein the electrode is a first
electrode and the cannula through which it is passed is a first
cannula; further comprising the steps of extending a second cannula
into the pericardium through the pericardial incision and passing a
second electrode into the pericardium through the second cannula so
as to position said second electrode on the opposite side of the
heart from the first electrode
3. A method according to claim 2 further comprising the step of
fastening the second electrode to the pericardium or the
surrounding connective tissue to hold the second electrode in a
generally fixed position within the pericardium.
4. A method according to claim 3, wherein the step of fastening the
second electrode to the pericardium or the surrounding connective
tissue comprises the steps of:
(a) sliding a crimping ring over the electrode;
(b) attaching said ring to the pericardium or the surrounding
tissue; and,
(c) crimping the ring to firmly grasp the electrode therein.
5. A method according to claim 4, wherein:
(a) a section of the cannula is left in place between the electrode
and button as the crimping ring is slid over the electrode;
and,
(b) the crimping ring is crimped onto the cannula to compress the
cannula into gripping engagement with the electrode.
6. A method according to claim 1 further comprising the step of
removing the guide wire after the cannula has been extended
thereover.
7. A method according to claim 6 further comprising the step of
removing the cannula while leaving the electrode in place within
the pericardium.
8. A method according to claim 1 wherein the guide wire has a
sharpened tip and is passed first through said one jaw to pierce
the pericardium and then enter into and pass through said other
jaw.
9. A method according to claim 1 wherein:
(a) the elongate jaws of the placement device include aligned
distal end portions capable of clamping the pericardium
therebetween and forming a puncture in the pericardium;
(b) after the jaws are passed into place said aligned distal end
portions are clamped on the pericardium to form a puncture therein;
and,
(c) after the puncture is formed the placement device is moved to
align the distal ends of the tubular jaws with the puncture and the
guide wire is then passed through the jaws and passes through the
puncture to extend through the pericardium.
10. A method according to claim 1, wherein:
(a) the open distal ends of the tubular jaws are sharpened;
(b) after the jaws are passed into place said open distal ends are
clamped on the pericardium to cut a hole therethrough; and,
(c) after the hole is formed the guide wire is passed through the
jaws and passes through the hole to extend through the
pericardium.
11. A method for accessing the interior of the pericardium,
comprising the steps of:
(a) creating a subxiphoid incision;
(b) dissecting a tunnel between the pericardium and the diaphragm
from the subxiphoid incision towards the posterior aspect of the
pericardium;
(c) making a pericardial incision in the inferior border of the
pericardium;
(d) providing a clamp-like placement device having elongate tubular
jaws with aligned open distal ends curved toward one another;
(e) passing one of the jaws through the pericardial incision to
locate the curved end of said one jaw within the pericardium
proximate to and interior surface thereof;
(f) passing the other of the jaws into the tunnel to the exterior
of the pericardium to locate the curved end of said other jaw
proximate to an exterior surface of the pericardium in alignment
with the curved end of said one jaw;
(g) passing a guide wire through the jaws to extend the wire within
and through the pericardium; and,
(h) removing the placement device while leaving the guide wire in
place.
12. A method according to claim 11 wherein the guide wire has a
sharpened tip and is passed first through said one jaw to pierce
the pericardium and then enter into and pass through said other
jaw.
13. A method according to claim 11 wherein:
(d) the elongate jaws of the placement device include aligned
distal end portions capable of clamping the pericardium
therebetween and forming a puncture in the pericardium;
(a) after the jaws are passed into place said aligned distal end
portions are clamped on the pericardium to form a puncture therein;
and,
(b) after the puncture is formed the placement device is moved to
align the distal ends of the tubular jaws with the puncture and the
guide wire is then passed through the jaws and passes through the
puncture to extend through the pericardium.
14. A method according to claim 11, wherein:
(a) the open distal ends of the tubular jaws are sharpened;
(b) after the jaws are passed into place said open distal ends are
clamped on the pericardium to cut a hole therethrough; and,
(c) after the hole is formed the guide wire is passed through the
jaws and passes through the hole to extend through the pericardium.
Description
BACKGROUND OF THE INVENTION
The present invention relates to a method and apparatus for
providing intrapericardial access with a minimal amount of surgery
and, more particularly, is concerned with an improved technique for
extending a guide wire through the pericardial wall. In its more
specific aspects, the invention is concerned with an improved
method for implanting defibrillation electrodes within the
pericardium.
Numerous efforts have been made to introduce implantable electrodes
with a minimal amount of surgery. These efforts have affected
placement both intrapericardially and extrapericardially. Where
intrapericardial placement was provided, however, the prior art
efforts have risked physical trauma to the heart during placement.
The present invention is designed to minimize this risk.
SUMMARY OF THE INVENTION
The method of the present invention provides access to the interior
of the pericardium through an incision in the inferior border of
the pericardium and a tunnel dissected between the pericardium and
the diaphragm. In the method, one jaw of a clamp-like placement
device is extended interiorly of the pericardium through the
incision and the other jaw is extended exteriorly of the
pericardium through the tunnel. The jaws include tubular guide
elements with aligned open distal ends curved toward one another.
Once placed relative to the pericardium, the jaw elements are moved
to clamp the tissue of the pericardium therebetween. A guide wire
is then extended through the tubular elements and the pericardial
tissue therebetween. Once the wire is so placed, the clamp-like
device is removed, leaving the wire in place to facilitate access
to the interior of the pericardium.
In the method of placing an electrode within the pericardium, a
guide cannula is extended over the wire and into the pericardium. A
primary electrode is then passed through the cannula and into the
interior of the pericardium. A secondary electrode may be inserted
through the incision in the inferior border of the pericardium.
The apparatus of the invention comprises the clamp-like placement
device, including first and second elongate jaw elements, each of
which has an open-ended tubular guide extending over the length
thereof and terminating in an open distal end extending laterally
of the element. It further comprises means for securing the jaw
elements together in a condition wherein the open distal ends of
the tubular guides are in aligned closely disposed relationship to
one another. In the preferred embodiment, the apparatus further
comprises means for holding the jaw elements in clamping engagement
with opposite sides of pericardial tissue and a secondary
open-ended tubular guide secured to and extending along at least
one of the jaw elements.
A principal object of the invention is to provide a method and
apparatus for accessing the interior of the pericardium with a
minimum of surgery and risk of physical trauma to the heart.
Another and more specific object of the invention is to provide
such a method and apparatus for extending a guide wire through the
pericardial wall, without risk that the wire will effect physical
trauma on the heart.
Still another object of the invention is to provide an improved
method for guiding an implantable defibrillator electrode into the
pericardium.
Yet another object of the invention is to provide an apparatus
having a simple mode of operation which may be used to pass a guide
wire into the pericardium with a minimum of surgery.
A more specific object of the invention is to provide such an
apparatus having means to create a puncture through the wall of the
pericardium.
A further object of the invention is to provide such an apparatus
having a secondary lumen adapted to be used for the introduction of
other elements into the pericardium.
These and other objects will become more apparent when viewed in
light of the following detailed description and accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a front prospective view of the upper chest region of a
human body, with parts thereof shown in section, illustrating the
electrodes of a defibrillator which have been implanted in the
pericardium through use of the method and apparatus of the
invention;
FIG. 2 is a cross-sectional side view of the body of FIG. 1;
FIG. 3 is a side elevational view of a curved probe which may be
used to dissect a tunnel between the pericardium and diaphragm in
the method of the present invention;
FIG. 4 is a perspective view illustrating a preferred embodiment of
the intrapericardial access apparatus;
FIGS. 5 to 15a are cross-sectional side views of the upper region
of a human body, sequentially illustrating the steps of practicing
the present invention to first access the interior of the
pericardium and then place defibrillator electrodes therein;
FIG. 15b is a cross-sectional elevational view, with parts thereof
broken away, illustrating a modification of the arrangement shown
in FIG. 15a, wherein the electrode within the anterior pericardial
space is secured to the pericardium through means of a crimpable
button;
FIG. 16 is an exploded perspective view of a first alternative
embodiment of the intrapericardial access apparatus;
FIG. 17 is a perspective view of a second alternative embodiment of
the intrapericardial access apparatus;
FIG. 18 is a cross-sectional view of the chest region of a human
body, illustrating the first alternative embodiment access
apparatus in the process of being positioned to extend to either
side of the lower wall of the pericardium;
FIG. 19 is a cross-sectional elevational view similar to FIG. 18,
illustrating the first alternative embodiment access apparatus in
the process of being used to extend a guide wire through the lower
wall of the pericardium;
FIG. 20 is a side elevational view of a coiled electrode which may
be placed through means of the method and apparatus of the present
invention; and,
FIG. 21 is a front elevational view of the FIG. 20 electrode, taken
on the plane designated by line 21--21 of FIG. 20.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
The chest region of the human body shown in the drawings is
designated in its entirety by the letter "C" and is illustrated to
show the pericardium "P", the heart "H", the diaphragm "D" and the
forward rib cage "R". As shown in FIGS. 1 and 2, an electrode
"E.sub.1 " is shown posteriorly positioned within the pericardium
and electrode "E.sub.2 " is shown anteriorly positioned within the
pericardium. The electrodes "E.sub.1 " and "E.sub.2 " shown in
FIGS. 1 and 2 have been placed through means of the method and
apparatus of the present invention. The process for this placement
is described in detail in the following discussion.
The curved probe shown in FIG. 3 is designated in its entirety by
the numeral 10. This probe is fabricated of a rigid material, such
a stainless steel, and finished so as to have a smooth exterior
surface. Its purpose, as will become more apparent from the
following discussion is to enable a surgeon to dissect a tunnel
between the pericardium and diaphragm through a subxiphoid incision
formed in the chest wall.
The preferred embodiment intrapericardial access apparatus of FIG.
4 is designated in its entirety by the numeral 12. This apparatus
is of a forceps construction embodying upper and lower elongate jaw
elements 14 and 16, respectively, similar to those used for
tenaculum forceps. The jaw elements are hingedly secured together
for movement toward and away from each other by a hinge pin 18. The
distal ends of the jaw elements 14 and 16 are formed with rigid
aligned lateral extensions 20 and 22, respectively. These
extensions, as will become more apparent from the following
discussion, are pointed and provided to clampingly engage the
tissue of the pericardium therebetween. Handles 24 and 26 are
rigidly affixed to the jaw elements 14 and 16, respectively, and
terminate in thumb and finger rings. Interengageable ratchet
elements 28 and 30 are formed on tee handles 24 and 26 to
selectively lock the handles in a condition wherein the extensions
20 and 22 are clampingly engaged with pericardial tissue.
A first primary open-ended tubular guide 32 is fixed to and extends
over the outer side of the jaw element 14 and terminates in a open
distal end 34 extending laterally of the element. A second
open-ended tubular guide 36 is fixed to and extends over the jaw
element 16 and terminates in an open distal end 38 extending
laterally of that element. The ends 34 and 38 are axially aligned
when the jaw elements are clampingly engaged with the pericardial
tissue and, in the preferred embodiment, are of such relative
diameters that the end 38 may fit within the end 34. The edges of
the ends may be sharpened to cut through the pericardial tissue
upon being clamped into engagement therewith.
A secondary open-ended tubular guide 40 is fixed to and extends
along the guide 32. The guide 40 terminates in a bias cut open end
short of the distal end 34. The purpose of the secondary lumen is
to provide additional access into the interior of the pericardium
for the insertion of instruments such as: a secondary guide wire;
an irrigation catheter; or a fiberoptic scope.
FIGS. 5 to 15a sequentially illustrate the steps of the inventive
method in the process of accessing the interior of the pericardium
and implanting defibrillator electrodes within the pericardium to
the posterior and anterior of the heart. At the outset of the
procedure, a subxiphoid incision 42 is formed in the chest wall.
The method of the invention is then carried out through the
following steps:
1. A pair of clamps or forceps 44 are used to pick up the inferior
border of the pericardium "P" through the subxiphoid incision (FIG.
5). This is carried out under direct vision.
2. A curved probe, such as the probe 10 is used to dissect a tunnel
"T" between the pericardium "P" and the diaphragm "D", towards the
posterior aspect of the pericardium (FIG. 6). This is also carried
out under direct vision, while the inferior border of the
pericardium is held by the forceps 44.
3. A small nick 46 is cut through the inferior border of the
pericardium (FIG. 7). This is carried out under direct vision,
using a scalpel 48 while the border of the pericardium is held with
the clamp 44.
4. The intrapericardial access apparatus 12 is inserted through the
incision 42 to extend the lower jaw element 16 into the tunnel "T"
and the upper jaw element 14 into the pericardium through the nick
46 (FIG. 8). This step is carried out while the inferior border of
the pericardium is held by the forceps 44, with the jaw elements of
the apparatus 12 sufficiently spread to pass to either side of the
lower wall of the pericardium.
5. The jaw elements of the access apparatus are snapped together,
trapping the tissue of the pericardium between them (FIG. 9).
During this process, the pointed lateral extensions 20 and 22 on
the elements pierce and grip surface of the tissue, thus gripping
and stabilizing the apparatus relative to the pericardium. The
ratchet elements 28 and 30 interengage upon snapping of the jaws
together to hold the jaws in the closed condition.
6. The next step is to pass a guide wire into the pericardium and
through the lower pericardial wall (FIG. 10). Depending upon the
choice of the surgeon, this may be achieved by slightly different
techniques. In one, a guide wire with a sharpened tip is extended
through the upper tubular guide 32 to exit therefrom and pierce
through the pericardial 10 wall and pass into the lower tubular
guide 36, from whence it is extended out through the subxiphoid
incision. In another, after the apparatus is locked in place, it is
moved back and forth to form a somewhat enlarged opening in the
pericardial wall where it is pierced by the extensions 20 and 22
and then the apparatus is pulled backwards to position the distal
ends of the tubular guides 36 and 38 in alignment with this hole.
The guide wire, designated 50, is then extended through the inner
tubular guide 32, passed through the enlarged opening, and exited
out through the outer tubular guide 32. In yet another, sharpened
edges 34.sub.a and 38.sub.a on the distal ends of the tubular
guides are used to cut a hole through the pericardial wall and then
the guide wire is passed from the upper tubular guide 32, through
the hole and into the lower tabular guide 36. The latter technique
does not require a sharpened tip on the guide wire. Regardless of
which technique is used, the guide wire 50 is passed from the
intrapericardial to the extrapericardial portion of the apparatus
to prevent any chance of myocardial injury should the wire pass
outside of the placement apparatus.
7. The intrapericardial access apparatus 12 is unsnapped and
removed, leaving the guide wire 50 in place (FIG. 11). As so
placed, the guide wire may be used for accessing the interior of
the pericardium for any desired purpose. The steps hereinafter set
forth are for the purpose of introducing defibrillation electrodes
into the intrapericardial space.
8. A dilator 52 and cannula 54 are threaded over the guide wire,
through the extrapericardial tunnel "T" into the intrapericardial
space (FIG. 12). During this step, the dilator is first extended
through the hole pierced in the lower wall of the pericardium to
enlarge this hole and the cannula is then extended thereover and
through the hole. Thereafter the dilator is withdrawn, leaving the
cannula in place.
9. With the cannula 54 in place, the dilator 52 is removed and the
electrode "E.sub.1 " is advanced through the cannula into position
in the posterior intrapericardial space (FIG. 13). The electrode
"E.sub.1 " may be of the resilient helical coil type disclosed in
copending application Ser. No. 120,124, filed Nov. 12, 1987. Such
electrodes are capable of being straightened into a generally
rectilinear configuration to facilitate advancing them through a
cannula and, when released, assume a three-dimensional helical coil
configuration as may be seen in FIGS. 20 and 21 herein.
10. After the posterior electrode "E.sub.1 " is in place, the
cannula 54 is removed and a second cannula 56 having the electrode
"E.sub.2 " threaded therethrough is advanced into the anterior
pericardial space through the inferior pericardial nick or incision
46 (FIG. 14).
11. The electrode "E" is passed through the cannula 56 to unfurl
into the anterior pericardial space and the cannula 56 is then
removed (FIG. 15A). The nick 46 is then closed with a suture, thus
securing the electrode "E.sub.2 " in place. The electrode "E.sub.1
" is held in position by virtue of its passage through the tunnel
"T" between the pericardium and the diaphragm.
As an alternative to suturing the anterior electrode "E.sub.2 " in
place as described above, the electrode may be held in place with a
crimpable annular button 58 (FIG. 15B) of the type disclosed in
copending application Ser. No. 120,590. With this arrangement, a
section of the second cannula, designated 56a, is left in place
around the electrode "E.sub.2 " and the button is crimped into
engagement with this section and sutured to the wall of the
pericardium.
The first alternative embodiment of the access apparatus shown in
FIG. 16 is designated in its entirety by the numeral "60". This
apparatus comprises: an upper jaw element 62 of an open-ended
tubular configuration having an open distal end 64 extending
laterally therefrom; a lower jaw element 66 of an open-ended
tubular configuration having an open distal end 68 extending
laterally therefrom; a T-shaped block 70 fixed to the element 62,
said block including a tongue-like extension 72; and, a block 74
fixed to the jaw element 66 and having a socket 76 therein for
complimental receipt of the tongue-like extension 72. The blocks 70
and 74 are so positioned relative to the elements 62 and 66 that
the distal ends 64 and 68 assume an axially aligned condition when
the extension 72 is received within the socket 76. The element 62
is so proportioned relative to the element 66 that the distal end
64 may be received within the distal end 66 when the extension 72
and groove 76 are complimentally engaged.
The apparatus 60 is used in a manner corresponding to that of the
apparatus 12, with the exception that the jaw elements of the
apparatus 60 may be inserted into place individually and that the
apparatus includes no pointed lateral extensions, such as the
extensions 20 and 22. FIGS. 18 and 19 show the manner in which the
apparatus 60 would be placed to extend a guide wire through the
lower wall of the pericardium. It should be appreciated that the
guide wire 50 would be provided with a sharpened tip and extended
from the upper jaw element 62 through pericardium and into the
lower jaw element 66.
The second alternative embodiment apparatus of FIG. 17 is
designated in its entirety by the numeral "60.sub.a ". The parts of
the apparatus "60.sub.a " are similar to those of the apparatus
"60" and designated by like numerals, followed by the subscript "a"
as follows: upper jaw element 62.sub.a ; open distal end 64.sub.a ;
lower jaw element 66.sub.a ; open distal end 68.sub.a ; block
70.sub.a ; tongue-like extension 72.sub.a ; block 74.sub.a ; and
socket 76.sub.a . The block 70.sub.a is pivotally secured to the
block 74.sub.a by a hinge pin 78 and is moveable about this pin
between the open condition illustrated in FIG. 17 and a closed
condition wherein the distal end 74.sub.a is received within the
distal end 68.sub.a.
The operation of the apparatus 60 corresponds to that of the
apparatus 60, with the exception that the surgeon has the option of
inserting the apparatus into place as shown in FIG. 18 with the
blocks 70.sub.a and 74.sub.a hingedly interconnected.
Alternatively, he may insert them individually and hingedly secure
them together after they are in place.
CONCLUSION
From the foregoing detailed description, it is believed apparent
that the present invention provides a method and apparatus whereby
intrapericardial access may be provided with minimal surgery and
risk of physical trauma to the heart. It should be understood,
however, that the invention is not intended to be limited to the
specifics of the described embodiments, but rather is defined by
the accompanying claims.
* * * * *